Finished device definition

Finished device means any device or accessory to any device that is suit- able for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.
Finished device means a device, or any accessory to a device, that is suitable for use, without regard to whether it is packaged or labelled for commercial distribution.
Finished device means any Product that constitutes a device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled or sterilized.

Examples of Finished device in a sentence

  • Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.

  • Finished device manufacturers who choose to conduct product quality control solely in-house must still assess the capability of suppliers to provide acceptable product.Some organizations require suppliers to maintain various types of certifications or registrations.

  • Finished device testing carried out for the Hailie® sensor indicates it meets design, safety, and performance requirements.

  • The following four categories of parties must submit a 510(k) to the FDA: Domestic manufacturers introducing a device to the U.S. market; Finished device manufacturers must submit a 510(k) if they manufacture a device according to their own specifications and market it in the U.S. Accessories to finished devices that are sold to the end user are also considered finished devices.

  • Finished device manufacturing sites that have been inspected in less than two years from the filing date of the PMA application, for which the inspectional outcome was No Action Indicated or Voluntary Action Indicated and for which the inspectional coverage is relevant to this PMA, may not be inspected until after approval of the EAP Device.

  • Finished device manufacturing sites with no prior inspectional history or inspectional history that is 5 or more years old, measured from the filing date of the application, would be inspected before approval of the EAP Device.

  • Finished device samples are to be tested in accordance with the requirements of current USP methodology for Sterility Tests.

  • Finished device - A device, or any accessory to a device, which is suitable for use, whether or not packaged or labeled for commercial distribution.

  • Finished device manufacturing sites that have been inspected in less than 2 years from the filing date of the PMA, for which the inspectional outcome was No Action Indicated or Voluntary Action Indicated and for which the inspectional coverage is relevant to this PMA, may be inspected after approval of the EAP Device.

  • Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled or sterilized.


More Definitions of Finished device

Finished device shall have that same meaning set forth in 21CFR§820.3.
Finished device under 21 CFR 820.3(l) means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.
Finished device. “Delivered Device” means a Device that has been produced at CCC and: (i) has been shipped to a destination indicated by EndoStim; or (ii) has entered into CCC’s stock of finished products and is ready to ship; or (iii) has been held at any other production stage upon EndoStim request.
Finished device means any device or accessory to any device that issuitable for use or capable offunctioning, whether or not it is packaged, labeled, or sterilized.

Related to Finished device

  • Finished Goods means completed goods which require no additional processing or manufacturing to be sold to third party customers by the Loan Parties in the ordinary course of business.

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • SKU means stock keeping unit.

  • Finished Products means any one or more of the following petroleum oils, or a mixture or combination of these oils, to be used without further processing except blending by mechanical means:

  • Vapor product means any:

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Manufacturing Site means a location where a manufacturing

  • Packaged means bottled, canned, cartoned, or securely wrapped.

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Sampler means a person who is employed by or is an owner of a licensed laboratory, grower, or processor and is authorized by that employer to collect samples in accordance with the testing laboratory's standard operating procedures and these Rules.

  • API means American Petroleum Institute.

  • shipped includes removal from the work sites by ship or any other means;

  • Finished grade means the grade upon completion of the fill or excavation.

  • Active Ingredient means any com- ponent that is intended to furnish pharmacological activity or other di- rect effect in the diagnosis, cure, miti- gation, treatment, or prevention of dis- ease, or to affect the structure or any function of the body of humans. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.

  • Raw Materials means all raw materials, supplies, components and packaging necessary to manufacture and ship the Product in accordance with the Specifications, as provided in Exhibit A, but not including the API.

  • Manufactured or “Manufacturing” means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.

  • Spray buff product means a product designed to restore a worn floor finish in conjunction with a floor buffing machine and special pad.

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

  • Filtering facepiece (dust mask) means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

  • Recycled product means a product containing recovered material, or post-consumer recovered material, or both.

  • Inert ingredient means an ingredient which is not an active ingredient.